Is Laryngeal Ultrasound Useful in the Assessment for ILO? A Protocol for a Two-stage Exploratory Pilot Study

Vocal Cord Dysfunction Clinical Trial

Official title:

Is Laryngeal Ultrasound a Useful Tool in the Assessment of Inducible Laryngeal Obstruction? A Protocol for a Two-stage Exploratory Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686941
• Other study ID #: 298631
• Status: Recruiting
• Start date: August 24, 2022
• Est. completion date: June 27, 2025

Study information

• Verified date: February 2024
• Source: Lancashire Teaching Hospitals NHS Foundation Trust
• Contact: Claire Slinger
• Phone: 01171523237
• Email: claire.slinger[@]lthtr.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a feasibility study to see if an ultrasound scan of the vocal cords can detect narrowing of the vocal cords as seen in a condition called inducible laryngeal Obstruction (the vocal cords narrow or close on breathing in, which makes it very difficult to breathe).

Description:

This study aims to help understand whether viewing the vocal cords with an ultrasound device is useful to detect the movement of the vocal cords during breathing. This study is useful, as some people who have abnormal movements of the vocal cords on breathing in find it more difficult to breathe in, and often this leads to a big impact on their quality of life. It may also mean they are on medications that they may not need not be on, as abnormal movements of the vocal cords can often be mistaken for asthma, so they may have been placed on asthma medication when they may not need to be. Usually, the way the abnormal movements of the vocal cords are seen now is via a small camera is placed via the nose into the throat to directly look at the vocal cords. Some people find this uncomfortable and may have to wait for a long time for it to happen. Also, this procedure is expensive, and is done in an endoscopy theatre, which may make it more daunting for some people, and make the wait longer. There are only a few centres that do these assessments with the camera, so people may have to travel some distance to have an assessment. It is hoped, by doing this study, the investigators can see whether ultrasound can help assess if people have abnormal vocal cord movements when they breathe in. This will be done in 2 stages, one with healthy volunteers, and the second stage in patients who have been referred for assessment of their vocal cords to see if they have abnormal movements when breathing in. The investigators will also ask the volunteers and patients what their experience of having the ultrasound was like, and will ask the patients in the study how the ultrasound scan felt, when compared to the camera test

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 27, 2025
• Est. primary completion date: June 27, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Healthy volunteers:

• No definite signs or symptoms of vocal fold paralysis
• No voice change
• No history laryngeal surgeries
• No History of pathology
• No uncontrolled Respiratory disease

Exclusion Criteria:

• Participants with a known vocal fold pathology
• Participants with a history of head and neck surgery.

Related Conditions & MeSH terms

• Asthma Brittle
• Vocal Cord Dysfunction

Intervention

Other:
• Trans-cutaneous Laryngeal ultrasound (TLUS)
Assessment of the larynx (specifically the vocal cords) with hand held portable ultrasound device to assess the movements of the vocal cords
• TLUS and simultaneous laryngoscopy
Assessment of the larynx (specifically the vocal cords) with hand held portable ultrasound device to assess the movements of the vocal cords with simultaneous video laryngoscopy (usual care)

Locations

Country	Name	City	State
United Kingdom	Lancashire Teaching Hospitals NHS Trust	Preston	Lancashire

Sponsors (5)

Lead Sponsor	Collaborator
Lancashire Teaching Hospitals NHS Foundation Trust	Edge Hill University, Lancaster University, University College, London, University of Central Lancashire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of vocal cords that are seen with the ultrasound	Can the vocal cord be seen under TLUS for Healthy Volunteers? Numeric data.	1 day
Primary	Number of particpants where visualisation of mimicked inspiratory adduction is visible on ultrasound	Can the vocal cords be seen to adduct under TLUS when healthy volunteers mimic ILO? Binary outcome: yes or no.	1 day
Primary	To assess the sensitivity, specificity and positive predictive value of the use of ultrasound	To assess the sensitivity, specificity and positive predictive value of the use of ultrasound in the assessment of ILO, using Laryngoscopy as reference standard in the patient population (n=30)	1 day
Primary	Questionnaire Investigating user perspectives on the acceptability of TLUS	A qualitative questionnaire investigating the patient and healthy volunteer perspectives on their experiences of undergoing TLUS assessment of the vocal cords. The questionnaire will look at the acceptability of the assessment in terms of comfort, repeatability, and comparison with laryngoscopy (for patients only).	1 day